Healthcare ProfessionnalsHERBASNCT05373849
Evaluation of the Efficacy of Aromatherapy on the Well-being of Healthcare Professionals
A study of Healthcare Professionnals, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial summary
The main objective is to evaluate the efficacy of aromatherapy (inhaler sticks) on the well-being of healthcare professionals practicing in medical and surgical intensive care unit, operating room/anesthesia and emergency departments Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthcare Professionnals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to 27 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare professional ;
- Working in a medical or surgical intensive care unit or in a operating room/anesthesia unit or in the emergency department;
- Agrees not to use any topical, oral or inhaled essential oils during the two study periods, other than those specified in the study protocol;
- Written informed consent;
Who cannot join
- Pregnant or breastfeeding woman;
- Known allergies to essential oils;
- Asthma;
- Scheduled departure from the unit;
- Antidepressant treatment or anxiolytic treatment;
- Taking topical, oral or inhaled essential oils durink the week prior to inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Aromatherapy on the Well-being of Hospital Healthcare Professionals: a Randomized Cross-over Trial
The main objective is to evaluate the efficacy of aromatherapy (inhaler sticks) on the well-being of healthcare professionals practicing in medical and surgical intensive care unit, operating room/anesthesia and emergency departments
Read the detailed description
The secondary objectives of this study are :
- To evaluate the efficacy of aromatherapy on anxiety of healthcare professionals;
- To evaluate the efficacy of aromatherapy on stress symptoms of healthcate professionals;
- To assess compliance with aromatherapy.
Conduct of research:
All participants included in the study will receive the study treatment (essential oils mixtures in inhaler sticks for 2 months) and the control (no intervention for 2 months), in random order. At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed.
- Conditions
- Healthcare Professionnals
- Being tested
- essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2), no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)
- Keywords
- Aromatherapy, stress, anxiety, quality of life, critical care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2)Dietary supplement
The participant will receive the study treatment (essential oils mixture in inhaler sticks for 2 months) and the control (no intervention for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed
no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)Dietary supplement
The participant will receive the control (no intervention for 2 months) and the study treatment (essential oils mixture in inhaler sticks for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy first then no intervention | Experimental | The participant will receive the study treatment (essential oils mixture in inhaler sticks for 2 months) and the control (no intervention for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed Receives: Dietary Supplement: essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2); Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2) |
| No intervention first then Aromatherapy | Experimental | The participant will receive the control (no intervention for 2 months) and the study treatment (essential oils mixture in inhaler sticks for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed. Receives: Dietary Supplement: essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2); Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization index of well-being
The World Health Organization well-being index consists of 5 items with 6 response modalities distributed on a frequency scale from 0 to 5. A global score is obtained by adding the answers to the 5 items, then multiplying this result by 4, i.e. a global score varying from 0 to 100. 0 is the worst score possible and 100 is the best score possible.
Measured: Through study completion, 4 months
Secondary outcomes (3)
Spielberger General Anxiety Questionnaire
The Spielberger General Anxiety Questionnaire consists of 20 items with 4 response modalities distributed on a frequency scale from 1 to 4 (the scoring of some questions being reversed). A global score between 20 and 80 is obtained by adding the answers to the 20 items.
For women the average score is 47.13.For men the average score is 39.27. A score above these averages indicates an anxious personality. The higher the score, the greater the anxiety. For men, a score higher than 51 indicates significant anxiety that interferes with quality of life. For women, a score higher than 61 indicates significant anxiety that interferes with quality of life.
Measured: Through study completion, 4 months
Perceived Stress Scale
The Perceived Stress Scale is a 10-item scale with 5 response modalities distributed on a frequency scale from 0 to 4 (the scoring of some questions being reversed). A global score between 0 and 40 is obtained by adding the answers to the 10 items.
Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress
Measured: Through study completion, 4 months
Follow-up diary
Compliance collected using a follow-up diary in which the participant will enter the average daily use of the "rest" stick and the "work" stick over the past week
Measured: End of aromatherapy, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start9 May 2022
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthcare ProfessionnalsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373849
- Sponsor's protocol ID
- GHRMSA 1192
- Other IDs
- 2021-A02995-36
- Acronym
- HERBAS
- Status last verified
- Oct 2023
- First submitted
- 4 May 2022
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anne-Florence D, Samuel D, Cindy P, Marie D, Clement P. The Efficacy of Aromatherapy on Well-Being and Stress. Nurs Crit Care. 2026 Jan;31(1):e70270. doi: 10.1111/nicc.70270.
PubMed 41330862
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Aromatherapy on the Well-being of Hospital Healthcare Professionals: a Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT05373849
- Acronym / sponsor ID
- HERBAS / GHRMSA 1192
- Conditions
- Healthcare Professionnals
- Keywords
- Aromatherapy, stress, anxiety, quality of life, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to evaluate the efficacy of aromatherapy (inhaler sticks) on the well-being of healthcare professionals practicing in medical and surgical intensive care unit, operating room/anesthesia and emergency departments
Detailed description
The secondary objectives of this study are :
- To evaluate the efficacy of aromatherapy on anxiety of healthcare professionals;
- To evaluate the efficacy of aromatherapy on stress symptoms of healthcate professionals;
- To assess compliance with aromatherapy.
Conduct of research:
All participants included in the study will receive the study treatment (essential oils mixtures in inhaler sticks for 2 months) and the control (no intervention for 2 months), in random order. At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy first then no intervention | Experimental | Dietary Supplement: essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2), Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)The participant will receive the study treatment (essential oils mixture in inhaler sticks for 2 months) and the control (no intervention for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed |
| No intervention first then Aromatherapy | Experimental | Dietary Supplement: essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2), Dietary Supplement: no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)The participant will receive the control (no intervention for 2 months) and the study treatment (essential oils mixture in inhaler sticks for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthcare professional ;
- Working in a medical or surgical intensive care unit or in a operating room/anesthesia unit or in the emergency department;
- Agrees not to use any topical, oral or inhaled essential oils during the two study periods, other than those specified in the study protocol;
- Written informed consent;
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman;
- Known allergies to essential oils;
- Asthma;
- Scheduled departure from the unit;
- Antidepressant treatment or anxiolytic treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| essentiel oil mixtures in inhaler sticks (step 1) - no intervention (step 2)The participant will receive the study treatment (essential oils mixture in inhaler sticks for 2 months) and the control (no intervention for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed | Dietary supplement | Aromatherapy first then no intervention, No intervention first then Aromatherapy |
| no intervention (step 1) - essential oils mixture in inhaler sticks (step 2)The participant will receive the control (no intervention for 2 months) and the study treatment (essential oils mixture in inhaler sticks for 2 months). At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed. | Dietary supplement | Aromatherapy first then no intervention, No intervention first then Aromatherapy |
Primary outcome
World Health Organization index of well-being
Time frame: Through study completion, 4 months
The World Health Organization well-being index consists of 5 items with 6 response modalities distributed on a frequency scale from 0 to 5. A global score is obtained by adding the answers to the 5 items, then multiplying this result by 4, i.e. a global score varying from 0 to 100. 0 is the worst score possible and 100 is the best score possible.
3 secondary outcomes
Spielberger General Anxiety Questionnaire
Time frame: Through study completion, 4 months
Perceived Stress Scale
Time frame: Through study completion, 4 months
Follow-up diary
Time frame: End of aromatherapy, 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 41330862Anne-Florence D, Samuel D, Cindy P, Marie D, Clement P. The Efficacy of Aromatherapy on Well-Being and Stress. Nurs Crit Care. 2026 Jan;31(1):e70270. doi: 10.1111/nicc.70270.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthcare Professionnals, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization index of well-being (time frame: Through study completion, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05373849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.